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21 U.S. Code § 353a. Pharmacy compounding
(a) In generalSections 351(a)(2)(B), 352(f)(1), and 355 of this title shall not apply to a drug product if the drug product is compounded for an identified individual patient based on the receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient, if the drug product meets the requirements of this section, and if the compounding—
(1) is by—
(A)
a licensed pharmacist in a State licensed pharmacy or a Federal facility, or
(B)
a licensed physician,
on the prescription order for such individual patient made by a licensed physician or other licensed practitioner authorized by State law to prescribe drugs; or
(2)
(A)
is by a licensed pharmacist or licensed physician in limited quantities before the receipt of a valid prescription order for such individual patient; and
(B) is based on a history of the licensed pharmacist or licensed physician receiving valid prescription orders for the compounding of the drug product, which orders have been generated solely within an established relationship between—
(i)
the licensed pharmacist or licensed physician; and
(ii)
(I)
such individual patient for whom the prescription order will be provided; or
(II)
the physician or other licensed practitioner who will write such prescription order.